Postoperative Complications Clinical Trial
— PRESELECTOfficial title:
Preoperative Self-assessment for Cardio-pulmonary Risk Stratification
NCT number | NCT04156594 |
Other study ID # | PV7061 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 4, 2019 |
Est. completion date | February 17, 2023 |
Verified date | May 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This prospective study intends to development and validation a patient self-assessment questionnaire. The aim of the self-assessment, by questionnaire, is to estimate the risk of postoperative pulmonary complications (PPC).
Status | Completed |
Enrollment | 5500 |
Est. completion date | February 17, 2023 |
Est. primary completion date | February 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years and older - Operations in general anesthesia Exclusion Criteria: - < 18 Years - Pregnancy - Lack of cooperation |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Gupta H, Ramanan B, Gupta PK, Fang X, Polich A, Modrykamien A, Schuller D, Morrow LE. Impact of COPD on postoperative outcomes: results from a national database. Chest. 2013 Jun;143(6):1599-1606. doi: 10.1378/chest.12-1499. — View Citation
Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118. — View Citation
Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Eur Respir J. 2017 Mar 6;49(3):1700214. doi: 10.1183/13993003.00214-2017. Print 2017 Mar. Erratum In: Eur Respir J. 2017 Jun 22;49(6): — View Citation
Wijeysundera DN, Pearse RM, Shulman MA, Abbott TEF, Torres E, Ambosta A, Croal BL, Granton JT, Thorpe KE, Grocott MPW, Farrington C, Myles PS, Cuthbertson BH; METS study investigators. Assessment of functional capacity before major non-cardiac surgery: an international, prospective cohort study. Lancet. 2018 Jun 30;391(10140):2631-2640. doi: 10.1016/S0140-6736(18)31131-0. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pulmonary complications (PPC) | European Perioperative Clinical Outcome (EPCO) definitions | until hospital discharge up to 6 months after surgery | |
Secondary | Major Adverse Cardiac Events (MACE) | European Perioperative Clinical Outcome (EPCO) definitions | until hospital discharge up to 6 months after surgery | |
Secondary | New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses | New diagnoses in the context of the current hospital stay New pulmonary or cardiac diagnoses | until hospital discharge up to 6 months after surgery | |
Secondary | Duration of hospitalization (days) | Duration of hospitalization (days) | until hospital discharge up to 6 months after surgery | |
Secondary | in-hospital mortality | in-hospital mortality | until hospital discharge up to 6 months after surgery | |
Secondary | Length of stay in the intensive care unit (days) | Length of stay in the intensive care unit (days) | until hospital discharge up to 6 months after surgery |
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